AB1150 IMMUNOGENICITY AND SAFETY OF THE CORONOVAC AND BNT162b2 COVID-19 VACCINE IN PATIENTS WITH INFLAMMATORY RHEUMATIC DISEASES AND HEALTHY ADULTS: COMPARISON OF DIFFERENT VACCINES
Authors: S. Batibay, R. Koçak Ulucaköy, Z. Günendi, I. Fidan, G. Bozdayi, F. N. Göğüş
Journal: Annals of the Rheumatic Diseases (2022)

Background Having an autoimmune disease was an exclusion criterion in the efficacy and safety phase studies of vaccines against Covid-19 (1-2). In Turkey vaccination first started with the inactivated CoronaVac, then with the mRNA BNT162b2 vaccine. Although there are studies on vaccine efficacy and safety in adults with inflammatory rheumatic disease (IRD), there are still many unknowns (3-4). Objectives Primary outcome of this study is to determine the seroconversion (SC) rate after CoronaVac and BNT162b2 vaccines in adults with IRD and to compare it with a healthy control group. Secondary outcomes are to evaluate whether there are efficacy differences in the two vaccine types, and to investigate the effects of the biologic agent used in the patient group on the vaccine immunogenicity. Methods This prospective observational single center study was conducted at the Gazi University Hospital. Patients who were followed up in our outpatient clinic with IRD and who received two doses of either CoronaVac or BNT162b2 vaccines were included. Subjects with two doses one of these vaccine without IRD were included in the healthy control group. Patients who had Covid-19 infection before or during vaccination were excluded. The demographic characters were recorded. The interval between the two doses was 4 weeks. The blood samples of the patient and control groups were taken a minimum of two and a maximum of 12 weeks after the second dose. Anti-S antibodies against SARS-CoV-2 spike proteins were evaluated with the IgG Abbott kit, and a value above 50 arbitrary unit/ml was considered as positive SC. The neutralizing antibody titers were evaluated with the DIA.PRO kit, and cut-off value was above 1 Co/S. Results The SC rate was slightly lower among patients with IRD versus controls (84% vs 97%, p:0.002). The SC rate was 100% in all participants who received BNT162b2 both in the patient and control group. The IgG antibody level after CoronaVac was significantly lower than that of BNT162b2 vaccine (p:0.031) in both patient and healthy controls (p:0.001). Among patients with IRD, those on rituximab (RTX)(12/81, %14.8) had significantly less SC rate (5/12, 41.7%) compared to patients on other biologicals (63/69, 91.3%) (p&lt;0.001). Conclusion This study showed that all patients with BNT162b2 vaccine developed immunogenicity in patients with IRD, while there was a decreased antibody response with CoronaVac vaccine compared to the healthy control group. In particular, the use of RTX significantly reduces the SC rate. References [1]Polack FP, Thomas SJ, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 383(27):2603–2615. [2]Tanriover MD, Doğanay HL, et al. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. Lancet. 2021 Jul 17;398(10296):213-222. [3]Medeiros-Ribeiro AC, Aikawa NE, et al. Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial. Nat Med. 2021 Oct;27(10):1744-1751. [4]Furer V, Eviatar T, et al. Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study. Ann Rheum Dis. 2021 Oct;80(10):1330-1338. Table 1. Patients with IRD n:81 Healthy controls n:100 P value Age (mean±SD) 50.65±1.37 50.65±1.37 Female 58 65 -RA 35 N/A -SpA 14 -CTD 20 -FMF 4 -Vasculitis 8 -CoronaVac 61 70 -BNT162b2 20 30 Seroconvertion rate (%) 68/81 (84%) 97/100 (97%) 0.002 -CoronaVac 48/61 67/70 -BNT162b2 20/20 30/30 IgG (median) (IR) 0.001 -CoronaVac 275.8 (68.95-916.70) 1116.7 (477.70-2074.18) -BNT162b2 4007.20 (1904.65-10415.25) 5792.30 (3696.42-9419.85) Neutralization (median) (IR) p: 0.031 p: 0.552 -CoronaVac 1.97 (0.92-6.82) N/A -BNT162b2 16.34 (13.85-16.67) bDMARD/Seroconvertion rate (%) p: 0.001 N/A -naive 52/58 -RTX 5/12 -Anti-cytokine 11/11 Acknowledgements Research support from:TRASD (Turksih League Against Rheumatism) Disclosure of Interests None declared